Class II

Medical Device Recall: stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented

Tornier, Inc · March 3, 2025

Reason for Recall

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

Distribution

OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany

Quantity Affected

5 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1651-2025

Status: ongoing

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